Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07400107 | AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight | PHASE3 | NOT YET_RECRUITING | 1,000 | — | — | May 20, 2026 | Jan 26, 2029 | Mar 12, 2026 | 120 | United States, Argentina +12 |
| NCT07567001 | A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity | PHASE3 | NOT YET_RECRUITING | 5,610 | — | — | May 11, 2026 | Aug 15, 2029 | May 5, 2026 | 825 | United States, Argentina +25 |
| NCT07571005 | AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea | PHASE3 | RECRUITING | 300 | — | — | May 5, 2026 | Oct 4, 2028 | Jun 2, 2026 | 80 | United States, Australia +8 |
| NCT07571109 | AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea | PHASE3 | RECRUITING | 300 | — | — | May 5, 2026 | Aug 21, 2028 | May 22, 2026 | 91 | United States, Australia +8 |
| NCT07503210 | AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss | PHASE3 | RECRUITING | 600 | — | — | Apr 21, 2026 | Jul 4, 2028 | Jun 2, 2026 | 72 | United States, Argentina +10 |
| NCT07509307 | AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain | PHASE3 | RECRUITING | 400 | — | — | Apr 20, 2026 | Aug 14, 2028 | Jun 2, 2026 | 81 | United States, Australia +9 |
| NCT07481630 | A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain | PHASE3 | RECRUITING | 400 | — | — | Apr 13, 2026 | Aug 14, 2028 | Jun 2, 2026 | 82 | United States, Australia +8 |
| NCT07339423 | AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight | PHASE3 | RECRUITING | 1,150 | — | — | Feb 24, 2026 | Aug 21, 2029 | Jun 2, 2026 | 72 | United States, Argentina +7 |
| NCT06064006 | A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin | PHASE2 | COMPLETED | 125 | — | — | Sep 15, 2023 | Nov 27, 2024 | Nov 19, 2025 | 2 | United States |
| NCT07508020 | A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity | PHASE1 | RECRUITING | 120 | — | — | Mar 30, 2026 | Jan 22, 2028 | Apr 27, 2026 | 1 | Germany |
| NCT06478563 | A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity | PHASE1 | COMPLETED | 133 | — | — | Jun 27, 2024 | Jul 1, 2025 | Aug 11, 2025 | 1 | United States |
| NCT06049329 | A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity | PHASE1 | COMPLETED | 36 | — | — | Sep 14, 2023 | Dec 15, 2023 | Mar 5, 2025 | 1 | Japan |
Measured as percentage of body weight.
Measured in days.
Measured in days.
Measured as events/hour.
WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.
Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis- related disability.
Number of events
Number of events
Measured as percentage change of energy.
Measured as percentage change of energy.
Measured as percentage change of energy.
Measured as hours\*nanomoles per liter (h\*nmol/L)
Number of events
| Arm | Type | Description |
|---|---|---|
| NNC0487-0111 | EXPERIMENTAL | Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to NNC0487-011 s.c. once weekly. |
| NNC0487-0111 dose level 1 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 2 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Phase A: NNC0487-0111 (formulation D) | EXPERIMENTAL | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase A: NNC0487-0111 (formulation C) | ACTIVE_COMPARATOR | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase B: NNC0487-0111 (formulation D) | EXPERIMENTAL | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D). |
| Phase B: NNC0487-0111 (formulation C) | ACTIVE_COMPARATOR | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C). |
| Name | Type | Description |
|---|---|---|
| NNC0487-0111 | DRUG | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to NNC0487-0111) | DRUG | Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to semaglutide) | DRUG | Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo | DRUG | Placebo will be administered subcutaneously. |
| Placebo (matched to NNC0487-0111 ) | DRUG | Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (NNC0487-0111) | DRUG | Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection. |
| NNC0487-0111 (formulation D) | DRUG | Participants will receive NNC0487-0111 (formulation D) tablet once daily. |
| NNC0487-0111 (formulation C) | DRUG | Participants will receive NNC0487-0111 (formulation C) tablet once daily. |
Key Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening. * Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as ...